ex parte lee opinion

8/3/2019 Ex parte Lee Opinion

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UNITED STATES PATENT AND TRADEMARK OFFICE__________

BEFORE THE BOARD OF PATENT APPEALS

AND INTERFERENCES

__________

Ex parte FRANCIS Y.F. LEE

__________

Appeal 2011-002616

Application 10/850,072

Technology Center 1600

__________

Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L.

McCOLLUM,Administrative Patent Judges.

Opinion for the Board filed byAdministrative Patent Judge GRIMES.

Opinion Dissenting filed byAdministrative Patent Judge MILLS.

GRIMES,Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. 134 involving claims to a method

of treating cancer. The Examiner has rejected the claims for obviousness

and obviousness-type double patenting. We have jurisdiction under 35

U.S.C. 6(b). We reverse the obviousness rejections but affirm the double

patenting rejection.


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STATEMENT OF THE CASE

Claims 121-127 and 141-143 are on appeal. Claim 121 is

representative and is directed to a method of treating pancreatic or lung

cancer by administering, in combination, two compounds:

(a) Compound (1), which is also known as ixabepilone (Lee

Declaration,1

3), C-15-Aza-EpoB (Appeal Br. 7), 15-Aza-EpoB (id. at 8),

or BMS 247550 (id.), and

(b) antibody C225, which is also known as cetuximab (Appeal Br. 7).

The full text of claim 121 is reproduced in Appellants Claims Appendix(Appeal Brief 17).

Claims 121-127 and 141-143 stand rejected under 35 U.S.C. 103(a)

as obvious based on Danishefsky2

and Chen3

(Answer 3) or based on Vite4

and Chen (Answer 5). Claims 121-127 and 141-143 also stand rejected for

obviousness-type double patenting based on the claims of Lee5

in view of

Chen (Office Action mailed July 8, 2009, pp. 2-36).

1Declaration under 37 C.F.R. 1.132 of Francis Y.F. Lee, executed Feb. 19,

2009.2 Danishefsky et al., US 6,867,305 B2, Mar. 15, 2005.3

Chen et al., US 2002/0147198 A1, Oct. 10, 2002.4

Vite et al., WO 99/02514, Jan. 21, 1999.5

Lee, U.S. RE41,393 E, reissued June 22, 2010.6

The double-patenting rejection is not set out in the Answer but the record

shows that Examiner intended to maintain the rejection, as discussed in more

detail infra.


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I.

Issue

The Examiner has rejected all of the claims on appeal as obvious

based on either Danishefsky or Vite, combined with Chen (Answer 3, 5).

The Examiner finds that Danishefsky and Vite teach Compound (1) for

treating cancer (id. at 3-4, 6) and Chen teaches treatment of cancer using

cetuximab (id. at 5, 6). The Examiner concludes that it would have been

obvious to treat cancer, including lung or pancreatic cancer, using a

combination of Compound (1) and cetuximab because Danishefsky and Viteteach that Compound (1) is useful for treating cancer in combination with

other cancer-treating agents (id. at 4, 6).

Appellant contends that the references would not have made obvious

the specific combination of agents required by the claims (Appeal Br. 7-10).

Appellant also contends that he has provided evidence of synergism that

rebuts any prima facie case of obviousness (id. at 10-14).

The issues with respect to this rejection are:

Do the cited references support the Examiners conclusion that

treating pancreatic cancer or lung cancer with a combination of

Compound (1) and cetuximab would have been prima facie obvious?

If so, has Appellant presented evidence of unexpected results that

outweighs the evidence supporting the prima facie case of obviousness?

Findings of Fact Prima facie obviousness

1. The Examiner finds that Danishefsky discloses Compound (1)

recited in the claims (Answer 3). Appellant does not dispute this finding

(see Appeal Br. 7-8).


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2. Danishefsky teaches treatment of tumors in mice using Compound

(1) (aka C-15-Aza-EpoB) (Danishefsky, Fig. 33).

3. Danishefsky teaches that Compound (1) (aka BMS 247550) is

currently under clinical investigations (id. at col. 109, ll. 45-46).

4. Danishefsky teaches that its compounds and pharmaceutical

compositions . . . can be employed in combination therapies (id. at col. 59,

ll. 45-47), including in combination with other cancer-treatment agents (id.

at col. 60, ll. 2-14).

5. Appellant acknowledges that Vite teaches Compound (1) as anExample (Appeal Br. 9).

6. Vite teaches that its compounds are useful in the treatment of a

variety of cancers (Vite 8: 21).

7. Vite teaches that its compounds are also useful in combination

with known anti-cancer and cytotoxic agents (id. at 10: 10-11).

8. Chen teaches that anti-neoplastic agents include cetuximab

(Chen 19, 291).

Analysis Prima Facie Obviousness

We agree with the Examiner that the teachings of Danishefsky or

Vite, viewed in combination with Chen, would have made obvious the

method of the claims on appeal. Danishefsky and Vite disclose that

Compound (1) is useful in treating cancer, and both suggest combiningdifferent cancer-treatment agents. Chen discloses that cetuximab was also a

known anti-neoplastic agent. Therefore, it would have been obvious to

combine Compound (1) with cetuximab with a reasonable expectation that


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the combination would provide more effective cancer treatment than either

Compound (1) or cetuximab alone.

Appellant argues that Danishefsky discloses that Compound (1) was a

known compound, but Danishefskys invention was directed to different

epithilone derivatives (Appeal Br. 7-8); therefore [a]t best, what

Danishefsky teaches is the combination of the 12,13 desoxy epithilones and

other cytotoxic agents (id. at 8). Appellant also argues that Vites general

teaching of combining its compounds with other anti-cancer agents does

not teach or suggest the specific combination of Compound (1) withcetuximab (id. at 10), and that Chen gives a 3-page laundry list of the anti-

cancer agents, one of which happens to be cetuximab (id. at 8). Appellant

argues that these teachings would not have made obvious the instantly

claimed method.

We are not persuaded. Danishefsky and Vite provide evidence that it

was known in the art to treat cancer using combinations of known cancer-

treatment agents. The cited references also disclose that the two compounds

recited in the claims on appeal were known cancer-treatment agents, and

therefore would have made it obvious to treat cancers including lung

cancer and pancreatic cancer using the combination.

Findings of Fact Secondary Considerations

9. Appellant has provided a declaration under 37 C.F.R. 1.132(Declaration of Francis Y. F. Lee, signed Feb. 19, 2009).

10. The Lee Declaration presents data showing the effect of

Compound (1) (aka ixabepilone) in combination with cetuximab in treating


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human lung carcinoma L2987 xenografts in nude mice (Lee Declaration,

5).

11. The Lee Declaration compares the results of treating human lung

carcinoma with a combination of ixabepilone and cetuximab to the results of

treating lung carcinoma with either ixabepilone or cetuximab alone (id. at

6).

12. The Lee Declaration states that the combination therapy produced

an LCK (gross log 10 cell kills) of >3.8 and 75% cures, compared with an

LCK of 3.2 and 13% cures for ixabepilone alone and an LCK of 3 and 13%cures with cetuximab alone (id. (Table A-B)).

13. The Lee Declaration states that a second study of lung carcinoma

L2987 resulted in an LCK of >6.5 and 38% cures for the combination of

ixabepilone and cetuximab, compared to an LCK of 3.1 and 0% cures for

ixabepilone alone and an LCK of 2.4 and 0% cures for cetuximab alone

(id.).

14. The Lee Declaration states that the combination of the two

agents surprisingly yielded synergistic anti-tumor efficacy results for the

combination which were significantly superior to either of the single agent

ixabepilone alone, or, the single agent cetuximab alone (id. at 5).

15. The Lee Declaration presents data showing the treatment of lung

carcinoma A549 xenografts in nude mice with ixabepilone alone, cetuximab

alone, or ixabepilone in combination with cetuximab (Lee Declaration, 8,

9).

16. The Lee Declaration states that the combination therapy produced

an LCK of 2.7 and a growth delay of 55 days, compared with an LCK of 1.2


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and a growth delay of 25 days for ixabepilone alone and an LCK of 0.7 and

a growth delay of 14.8 days with cetuximab alone (id. at 8 (Table C)).

17. The Lee Declaration states that treatment with the combination

was substantially more effective than each drug alone in tumor growth.

These results are indeed surprising, unexpected and synergistic (id. at 9).

18. The Lee Declaration presents data showing the treatment of

human pancreatic carcinoma Bx-PC3 xenografts in nude mice with

ixabepilone alone, cetuximab alone, or ixabepilone in combination with

cetuximab (Lee Declaration, 12).19. The Lee Declaration states that the combination therapy produced

a delay in tumor growth of 31.2 days, compared with 21.5 days with

ixabepilone alone and 5 days with cetuximab alone (id. (Table E)).

20. The Lee Declaration states that these results are surprising,

unexpected and synergistic given that the combination of ixabepilone and

cetuximab produced a significant delay in tumor increase over the

ixabepilone alone and the cetuximab alone (id.).

Principles of Law Secondary Considerations

One way for a patent applicant to rebut aprima facie case of

obviousness is to make a showing of unexpected results, i.e., to show that

the claimed invention exhibits some superior property or advantage that a

person of ordinary skill in the relevant art would have found surprising orunexpected. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).

Mere improvement in properties does not always suffice to show

unexpected results. In our view, however, when an applicant demonstrates

substantially improved results . . . and states that the results were


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unexpected, this should suffice to establish unexpected results in the absence

ofevidence to the contrary. Id. at 751.

If an applicant demonstrates that an embodiment has an unexpected

result and provides an adequate basis to support the conclusion that other

embodiments falling within the claim will behave in the same manner, this

will generally establish that the evidence is commensurate with [the] scope

of the claims. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).

Analysis Secondary Considerations

The Lee Declaration presents evidence showing the results of treating

human lung carcinoma and human pancreatic carcinoma in an animal model

with a combination of Compound (1) and cetuximab. The evidence

provided shows that treatment with the combination is more effective than

treatment with either agent alone (FFs 12, 13, 16, 19), and Dr. Lee has stated

that the results observed showed synergism and were unexpectedly superior

(FFs 14, 17, 20). Thus, Appellant has demonstrated substantially improved

results and stated that the results were unexpected; this should suffice to

establish unexpected results in the absence ofevidence to the contrary. In

re Soni, 54 F.3d at 751.

The Examiner responds that although the data can be considered

synergistic, they are based on a single dosage for each active agent. . . .

Examiner submits that a showing of a few data points regarding dosages willnot support the entire claimed range, which is any dosage amount.

(Answer 8-9.)

The Examiner, however, has not provided any evidence or technical

reasoning to support a conclusion that the results shown in the Lee


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Declaration would not be representative of other dosages. The Examiner

therefore has not provided an adequate basis for concluding that the data are

not commensurate with the scope of the claims. Cf. In re Kao, 639 F.3d at

1068.

The Examiner also argues that

it is not certain what conclusions can be gathered from Table A-

B. For example, the LCK and Tumor Growth Delay variables

for L2987 (Lung) No. 140 seem to show mere additive effects,

while the % cures seem to show synergism. In Table C, there

seems to be additive effects for LCK and synergism for Tumor

Growth Delay, while no data is given for % cures. The samegoes for Tables D-E. Taking all the data as a whole, it appears

that there are some synergistic results along with some additive

effects.

(Answer 9.)

This argument is also unpersuasive, because the Examiner has

provided no analysis of the data to show that they would have been expected

or do not show synergism. Dr. Lee has testified that the data showsynergistic results for the combination of ixabepilone and cetuximab,

compared to the results for either agent alone (FFs 14, 17, 20). If the

Examiners position is that Dr. Lees conclusion is not supported by the

evidence presented in the Lee Declaration, the Examiner must provide

adequate evidence or technical reasoning to show that the evidence does not

support the declarants conclusion. The Examiner, however, has provided

only conclusory statements of disagreement with Dr. Lees view of the

evidence, which is not adequate to cast doubt on the accuracy of the

evidence provided by the Lee Declaration.


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Conclusions of Law

The cited references support the Examiners conclusion that treating

pancreatic cancer or lung cancer with a combination of Compound (1) and

cetuximab would have been prima facie obvious, but Appellant has

presented evidence of unexpected results that outweighs the evidence

supporting the prima facie case of obviousness.

II.

In the Final Rejection, the Examiner rejected claims 121-127 and 141-

143 for obviousness-type double patenting based on the claims of either U.S.

Patent 6,686,380 B2 or U.S. Patent 7,312,237 B2, combined with Chen

(Office Action mailed July 8, 2009, pp. 2-3). The Examiner also

provisionally rejected claims 121-127 and 141-143 for obviousness-type

double patenting based on the claims of either co-pending application

11/009,579 or application 11/346,579, combined with Chen (id. at 3).

In the Appeal Brief, as a ground of rejection to be reviewed on appeal,

Appellant included [w]hether claims 121-127 and 141-143 are unpatentable

under the judicially created doctrine of obviousness-type double patenting

over claims 1-15 of US Patent 6,686,380 or claims 38-50 of US application

No. 11/346,579 (reissue application of US Patent 6,686,380) in view of

Chen (Appeal Br. 6). Appellant addressed these rejections on the merits

(id

. at 14-15).In the Answer, the Examiner did not repeat any of the double-

patenting rejections from the Final Rejection but stated that the appellants

statement of the grounds of rejection to be reviewed on appeal is correct

(Answer 2). The Examiner also responded to Appellants argument


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concerning the double patenting rejections, and concluded that it did not

overcome the rejection (id. at 10-11).

In the Reply Brief, Appellant noted that application 11/346,579 issued

as RE41,393 on June 22, 2010, effecting the surrender of the 380 patent and

thus the rejection based on claims 1-15 of US Patent 6,686,380 in view of

Chen is moot (Reply Br. 2, n.1). Appellant also noted that the rejections

outstanding after the Appeal Brief was filed were discussed by telephone on

May 11, 2010, and that Appellant was still of the opinion that the

obviousness-type double patenting rejection was improper and thus declinedto file a TD (id. at 3). Appellant again presented arguments addressing the

Examiners position on double patenting (id. at 6).

Based on the record, we understand the Examiner to maintain the

rejection of claims 121-127 and 141-143 for obviousness-type double

patenting based on application 11/346,5797

(now RE41,393) in view of

Chen. We understand the Examiners failure to reproduce this rejection in

the Answer to be an oversight rather than a decision to withdraw the

rejection. We note that Appellant apparently shared this understanding, as

indicated by the comments and argument in the Reply Brief regarding the

rejection.

The Examiner concludes that the claims of RE41,393, read in view of

Chen, are unpatentable for obviousness-type double patenting based on the

same reasoning as set forth in the 103(a) rejection (Office Action mailed

7The Examiner apparently also meant to maintain the double patenting

rejection based on the 380 patent but, as noted by Appellant, this rejection

is moot now that the 380 patent has been reissued as RE41,393.


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July 8, 1009, p. 3). That is, the reissued claims are directed to a method of

using Compound (1) to treat cancer and Chen teaches cetuximab to treat

cancer, in combination with other cancer-treating compounds, so the

combination therapy method of the instant claims is an obvious variation of

the method defined by the reissue claims (seeid. at 4-6 (reasoning of the

rejection based on 35 U.S.C. 103(a)).

We agree with the Examiners reasoning and conclusion.

Appellant argues that the showing of unexpected results in the Lee

Declaration rebuts the obviousness-type double patenting rejection for thesame reason that it rebuts the rejections based on 35 U.S.C. 103 (Appeal

Br. 14-15).

We agree, however, with the Examiner that while a Declaration

showing unexpected results can overcome a 103(a) obviousness rejection,

the same Declaration cannot overcome an obviousness double patenting

rejection (Answer 11). The Examiners position is supported by the case

law. SeeGeneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373,

1378 n.1 (Fed. Cir. 2003) (The distinctions between obviousness under 35

U.S.C. 103 and nonstatutory double patenting include: . . . Obviousness

requires inquiry into objective criteria suggesting non-obviousness;

nonstatutory double patenting does not.); Procter & Gamble Co. v. Teva

Pharms. USA, Inc., 566 F.3d 989, 999 (Fed. Cir. 2009) (In general, the

obviousness analysis applies to double patenting, except for three

distinctions. . . . Finally, double patenting does not require inquiry into

objective criteria suggesting non-obviousness.).


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Thus, unexpected results cannot be relied on to rebut a rejection for

nonstatutory, obviousness-type double patenting. Since the claims were not

argued separately, we affirm the rejection of claims 121-127 and 141-143.

37 C.F.R. 41.37(c)(1)(vii).

SUMMARY

We reverse the rejection of claims 121-127 and 141-143 under 35

U.S.C. 103(a) based on either Danishefsky and Chen or Vite and Chen.

We affirm the rejection of claims 121-127 and 141-143 for obviousness-type

double patenting based on the claims of RE41,393 in view of Chen.

TIME PERIOD FOR RESPONSE

No time period for taking any subsequent action in connection with

this appeal may be extended under 37 C.F.R. 1.136(a).

AFFIRMED


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18/24

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that the f

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41,393, an

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at

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1994).

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IS

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izer, 518

patent and. Second

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t

,


19/24

Appeal 2011-002616


19

Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).

Comparing the claims

The RE41,393 patented claims are to a method of treating a tumor

resistant to oncology therapy with taxane with a compound of the formula of

compound 1 (RE41,393 claim 16) which encompasses pending claim

compound 1 but does not encompass a method of treating cancer with a

combination therapy of compound 1 with antibody C225. Thus, the prior

patent claims and the pending claims are not to the same invention. Thedifference between the patented subject matter and the pending claimed

subject matter is the C225 antibody.

We then must determine whether this difference in the pending claims

renders the claim patentably distinct from the RE41,393 patent claims in

view of Chen. One way of determining this is inquiring whether the pending

claims are an obvious variant of the RE41,393 patent claims. This inquiry

follows.

The obviousness-type double patenting rejections are set forth in the

Final Rejection at pages 2-3.

In addition to the RE41,393 patent claims the Examiner relies on

Chen in the obviousness-type double patenting rejection for the disclosure of

the C225 antibody (cetuximab) for the treatment of cancer.

In determining patentable distinctiveness or obvious variant,

we ask whether the identified difference renders the claims of

the patents non-obvious to a person of ordinary skill in the art in

light of the prior art. See In re Kaplan, 789 F.2d 1574, 1580 (Fed.

Cir. 1986). This part of the obviousness-type double patenting

analysis is analogous to an obviousness analysis under 35 U.S.C.


20/24

Appeal 2011-002616


20

103. See In re Longi, 759 F.2d 887, 892 n.4 (Fed. Cir. 1985) ([A]

double patenting of the obviousness type rejection is analogous to [a

failure to meet] the non-obviousness requirement of 35 U.S.C. 103,

except that the patent principally underlying the double patentingrejection is not considered prior art. (quotation marks omitted)).

Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir.

2009).

Since the double patenting of the obviousness-type rejection is

analogous to a failure to meet the non-obviousness requirement of 35 U.S.C.

103, we look to relevant obviousness analysis. The question of

obviousness is resolved on the basis of underlying factual determinations

including: (1) the scope and content of the prior art; (2) the level of ordinary

skill in the art; (3) the differences between the claimed invention and the

prior art; and (4) secondary considerations of nonobviousness, if any.

Graham v. John Deere Co., 383 U.S. 1, 17 (1966).

This analysis was not performed by the Examiner and is error. TheExaminer merely determined that Appellants evidence of non-obviousness

in the Lee Declaration was not relevant to the obviousness-type double

patenting rejection. The majority agrees citing Geneva, fn1.

I respectfully disagree.

When the appropriate 103 analysis is performed, patentable

distinctiveness is found and the obviousness-type double patenting rejection

should be reversed.

In reviewing the obviousness rejections over Danishefsky or Vite and

Chen, the majority performed the 103 analysis ofGraham and concluded

that the Declaration of Lee provided convincing evidence of unexpected and


21/24

Appeal 2011-002616


21

synergistic results when compound 1 is combined with cetuximab. The

majority reversed the obviousness rejections based on secondary

considerations of non-obviousness.

I agree with the majoritys conclusion that the Declaration of Lee

overcomes the obviousness rejections. For the same reasons, I find that the

Declaration also overcomes the obviousness-type double patenting rejection

and shows patentable distinctiveness of the claimed invention. See also,In

re Procter and Gamble Co. v. Teva Pharms USA, Inc. 566 F.3d 989, 999

(Fed. Circ.2009) wherein the Federal Circuit determined that risedronate wasnot obvious under 103, considering a showing of long-felt need, and thus for

the same reason the obviousness-type double patenting rejection was not

affirmed.

Distinguishing Geneva and Pfizer

The Examiner assumes per se that a Declaration and secondary

considerations cannot overcome an obviousness-type double patenting

rejection. The majority cites Geneva and Procter & Gamble for this

proposition of law. I do not find this case law persuasive or relevant to the

pending facts. Moreover, [t]he use ofper se rules, while undoubtedly less

laborious than a searching comparison of the claimed inventionincluding

all its limitationswith the teachings of the prior art, flouts section 103 and

the fundamental case law applying it.In re Ochiai, 71 F.3d 1565, 1572

(Fed. Cir. 1995).

The facts before us are distinct from those ofGeneva cited by the

majority. The facts before us are not a claim to a method of using a

composition [which] is not patentably distinct from an earlier claim to the


22/24

App

App

iden

Gen

its s

met

for

pate

pan

antil. 14

cons

Circ

the

sho

type

sug

obvi

reas

pate

lega

10In

earli

eal 2011-

lication 1

tical com

eva, 349

ecific fac

To the c

od of trea

ula 1 (clai

nt does no

reatic and

ody C225-16)

10as

A caref

istent wit

uit determ

ederal Ci

ing of lo

double pa

In the p

est a pate

ousness-t

ns as the

Moreov

nting does

ly unsupp

Pfizer, th

er patent.

02616

/850,072

osition in

.3d at 138

s.

ontrary, th

ting a tum

m16. ) U

disclose

lung canc

(Imcloneresently cl

l review

the legal

ined that r

cuit, in ad

g-felt nee

tenting rej

esent case

tably disti

pe double

obviousne

r, footnot

not requir

orted and

newly cl

a patent di

5-86. The

e facts be

or which i

like Gen

a method

ers by ad

antibody iaimed.

fIn re Pr

precedent

isedronate

dition to 1

, and thu

ection wa

, as in Pro

nct invent

patenting

ss rejectio

e 1 in Gen

e objectiv

is simplex

imed use

22

sclosing t

holding i

ore us are

taxane r

va, the Sp

of treating

inistratio

mmunosp

cter and

cited here

was not o

03 consid

for the sa

not affir

cter, the s

ion is bein

rejection

ns.

eva, espo

criteria s

or obiter

was descri

e identic

Geneva

, RE41,39

sistant wi

ecificatio

cancer se

of the cl

ecific for t

amble su

in. In Pro

bvious un

rations, a

me reason

ed. 566

econdary

g claimed

hould be

sing that

uggesting

ictum to t

ibed in the

l use as s

hould be l

patented

h a comp

of the R

ected fro

imed com

he EGFR,

ggests a h

cterthe F

er 103. I

so consid

the obvio

.3d at 99

onsiderati

and that t

eversed f

on-statut

non-obvio

he Genev

specificat

et forth in

imited to

claims to

und of

41,393

pound wit

Spec. 24,

lding

deral

that case

red a

usness-

.

ons

e

r the sam

ry double

usness is

ion of the

a

h


23/24

Appeal 2011-002616


23

decision.11

To the contrary,In re Longi,759 F.2d 887, 897 (Fed. Cir. 1985)

considered whether unexpected results can overcome obviousness-type

double patenting rejection, implied that they could, but found them

unconvincing on the facts of that case. Moreover, the holding in Geneva

addresses the situation in which an earlier patent claims a compound,

disclosing the utility of that compound in the specification, and a later patent

claims a method of using that compound for a particular use described in the

specification of the earlier patent. Sun Pharmaceutical Industries Ltd. v.

Eli Lilly and Co., 611 F.3d 1381, 1384 (Fed. Cir. 2010). Those are not thefacts in the present case.

Therefore, in view of secondary considerations, the pending claims

define a patentably distinct invention from those of Lee RE41,393, and the

holding and dicta in Geneva is not germane to the facts in the present case.

2. Whether the secondary considerations such as unexpectedresults provide the patentee with a timewise extension of apatent for the same invention or an obvious modification

thereof.

It has long been recognized in the law that unobvious improvement

patents do not result in a timewise extension of a patent for the same

11

As the United States Supreme Court has put it: "dicta may befollowed if sufficiently persuasive but are not binding." Central Green

Co. v. United States, 531 U.S. 425 (2001), quotingHumphrey's

Executor v. United States, 295 U. S. 602, 627 (1935).


24/24

Appeal 2011-002616


invention or an obvious modification thereof. As there has been a showing

of patentable distinctiveness on the facts in the present case in the

Declaration of Lee, there is no timewise extension of a patent for the same

invention or an obvious modification thereof. The modification of

coadministering compound one with antibody C225 for the treatment of

specific cancers is an unobvious modification of the Lee Rexamined 380

claims. Further, when the patent term on the Lee Reexamined 380 patent

expires, the use of compound 1 for the treatment of taxane resistant cancers

by the public is no longer controlled by the patent, and thereafter, only thepatentably distinct use of the compound 1 in combination with antibody

C225 would be covered by a distinct patent term. Thus, no extension of

patent term would result.

CONCLUSION

The pending claims are partially encompassed by the Lee RE41,393

patent, however the pending claims are patentably distinct from the claims

of the Lee RE41,393 patent in view of Chen.

No timewise extension of patent protection results from patentability

of the pending claims.

For these reasons, the obviousness-type double patenting rejection

should be reversed.

lp

ex parte lee opinion

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